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Clinical Evaluation of a Fully Synthetic Middle Meatal Stent for Safety and Tolerability
Abstract
To evaluate the safety and tolerability of a novel, fully synthetic, poly-urethane middle meatal dressing after endoscopic sinus surgery (ESS).
Case series with planned data collection.
Tertiary care medical facility.
In total, 104 patients with medically refractory chronic rhinosinusitis were treated with patient-appropriate ESS and a poly-urethane sponge placed into their middle meatus at the end of operation, giving a total of 173 middle meatus stent placements. Patients were then assessed immediately postoperatively and 2, 6, 12, and 16 weeks after surgery for adverse systemic or local reaction to the stent and the incidence of postoperative infections.
There was no pain or allergic reaction encountered with this new material. There were 11 middle meati (6.4%; 95% confidence interval, 3.2%-11.1%) with postoperative infection at 2 weeks follow-up. There were no other stent-related local reactions (ie, excessive bleeding, middle meatal synechia, or granulation) up to 16 weeks postoperatively. Residual middle meatal stent material was either absent or negligible at 2 weeks postoperatively.
This first fully synthetic poly-urethane middle meatal dressing used during ESS demonstrated excellent biocompatibility and safety. The incidence of localized postoperative infection was also low.
... Several studies have evaluated a number of biodegradable middle meatal dressings showing good clinical outcomes [3][4][5][6]. A few examples include carboxymethylcellulose foam, collagen-based Gelfoam, hyaluronic acid based fi lm, and polyurethane sponges. ...
... However, some of these products have been associated with increased crusting, discomfort, and the need for aggressive debridement. One such example is a fully synthetic polyurethane sponge that has excellent biocompatibility and stabilizes the middle turbinate well, however, resorption is delayed (>7 days), the product is relatively stiff, and ease of use remains an issue among surgeons [4][5][6]. In particular, the polyurethane sponge is fully expanded at the time of insertion and therefore blocks the surgeon's view of the target during placement. ...
... On other hand, polyurethane foam nasal dressing used herein was found to have better biocompatibility, with improved wound healing and hemostasis compared to other types absorbable nasal dressings [4]. It has, therefore, become a very popular nasal dressing [4,6]. ...
p> Background: The benefi t from biodegradable middle meatal dressings is well established, and includes improved wound healing, stabilization of the middle turbinate, reduced granulation tissue, and improved patient comfort. This study compares the outcomes of a 100% plant-based nasal dressing to a popular fully synthetic dressing in patients undergoing endoscopic sinus surgery.
Design and Methods : A prospective study compared the clinical outcomes of two groups of patients undergoing endoscopic sinus surgery (ESS); the study group had a plant-based nasal dressing placed into the middle meatus, and the control group received a fully synthetic product. Outcome metrics included the degree of middle meatal crusting, amount of retained material during follow-up, need for debridement, wound healing, incidence of epistaxis, rate of post-operative infection, and patient comfort. Data was collected at 2 and 12 weeks after surgery. All patients underwent ESS for CRS and were matched for demographics and extent of disease.
Results: 25 patients were enrolled in the study group (50 dressings); the control group included 20 patients (40 dressings). The study group showed a statistically signifi cant reduction (p<.05) in nasal crusting, amount of retained implant, patient comfort, and the need for debridement compared to the control group. However, the rate of infection was slightly higher in the study group at 2 weeks.
Conclusion: Plant based middle meatal dressings appear superior to fully synthetic dressings with regards to wound healing, crusting, rate of fragmentation, and patient comfort. A slightly elevated incidence of infection was noted.</p
... Various types of resorbable MM dressings have demonstrated improvements in wound healing compared to non-resorbable dressings such as Vaseline gauze, silicon-stents, Merocel sponges, and finger cots stuffed with cotton. There is currently no standard or recommendation regarding the use or type of MM dressing that best achieves its desired purpose, and only a limited number of studies that offer a direct head to head comparison on the efficacy of different materials [3]. ...
... As part of this effort, multiple types of materials with different bioreactivity, biodegradability, and degradation kinectics have been investigated for their potential wound healing benefits. Thus far, a fully synthetic polyurethane sponge (Nasopore), has shown one of the most favorable biocompatibility and bioresorption profiles, with excellent wound healing characteristics [1,[3][4][5]. However, many surgeons find the degradation time of polyurethane to be too long (>7 days), and the size and stiffness of the foam affects ease of use for the surgeon. ...
... This study investigates and compares the wound healing and hemostatic characteristics, and patient comfort factors of two bioresorbable MM dressings, a Chitosan-based polymer (PosiSep X) and a well-known fully synthetic polyurethane foam sponge (NasoPore) in patients recovering from ESS [3]. ...
Introduction: The use of biomaterials to improve wound healing after endoscopic sinus surgery (ESS) is not new. Many types of resorbable and non-resorbable materials have been tried as a middle meatal (MM) dressing, spacer, or stent to prevent lateralization of the middle turbinate, formation of synechia, granulation tissue, adhesions and scarring. The FDA has recently approved Chitosan-based nasal dressing/spacers which have optimal wound healing characteristics, including hemostatic and bacteriostatic properties. Herein, we compare a new chitosan-based biomaterial to a popular fully synthetic resorbable dressing in patients undergoing ESS. Materials and Methods: A prospective randomized controlled study was performed comparing a new Chitosan-based bioresorbable nasal dressing (Posi-Sep X) against a previously studied and well known fully synthetic polyurethane-based control (Nasopore). Post-operative outcome metrics included the degree of crusting, amount of retained implant, patient comfort, wound healing, epistaxis, and post-operative infection at two weeks. Results: Thirty-five patients were enrolled and a total seventy implants were placed (n = 70) at the completion of ESS. The results show a statistically significant difference between the Chitosan-based product and the control with respect to wound healing, degree of crusting, and resorption profile. In addition, the Chitosan-based dressing had a markedly lower requirement for post-operative debridement, and a lower incidence of epistaxis and infection, which corresponds to superior patient comfort. Conclusion: Our study is consistent with the biomaterials literature regarding the potential advantages of Chitosan-based MM dressings after ESS regarding improved wound healing, biocompatibility, and patient comfort.
... The utilization of nonabsorbable materials, such as gauzes and Beskichin, has waned in standard practice, reserved for specific situations [2,3]. A divergence in approach is observed, with some surgeons opting not to use packing material at all [4,5] while others widely employ resorbable packing materials to support the middle meatus opening and facilitate hemostasis [2,6,7]. ...
... Established options like calcium alginate, Sorbsan, and polyurethane sponge, Nasopore have traditionally played pivotal roles in postoperative care [2,6,7]. However, recent challenges, including the discontinuation of Sorbsan and economic considerations associated with Nasopore, have accentuated the demand for innovative alternatives. ...
... 8 Several methods were tried to minimize re-stenosis of the sinus ostia such as the application of mitomycin C which inhibits fibroblast formation after surgery, 5 or placement of a stent or balloon catheter dilatation at the middle meatus. 15 Yet on experimental animal model, the placement of a stent at surgically enlarged maxillary sinus ostium increased the risk of stenosis. 16 The aim of this study is to evaluate the role of local rotational tissue flaps in minimizing contracture of the maxillary and sphenoid ostia. ...
... 5 Others used a stent or catheter with balloon at the surgically enlarged maxillary sinus ostium. 15 Yet, an animal model proved that this can increase the risk of stenosis. 19 The aim of our study was to utilize a new method to prevent re-closure of sinus ostia or at least to guarantee minimal degree of patency of the ostia if fibrosis is inevitable after endoscopic surgery, by applying local rotational flaps to cover the exposed bony edges of maxillary and sphenoid ostea after their enlargement using the standard techniques in order to decrease fibrosis and re-stenosis, and to examine the long-term patency of maxillary and sphenoid ostia (9 months post-operatively) when using these local rotational tissue flaps. ...
Introduction: There are several reasons for endoscopic surgery failure; some of the major causes are adhesion formation and osteal stenosis. The commonest anatomic finding in revision endoscopic surgery is an obstructed or stenosed ostium. Adhesion and stenosis after surgery are usually due to scar tissue or granulation formation during the tissue recovery process. The patency and the size of the sinus ostium and limiting cicatricial fibrosis are two significant factors in the evaluation of a successful endoscopic sinus surgery. To limit the spontaneous closure rate; several methods were used to prevent re-stenosis of the sinuses ostium such as the application of mitomycin C which inhibits fibroblast formation after surgery, or placement of a stent or balloon catheter dilatation at the middle meatus.
Objectives: The aim of this study is to evaluate the effect of local rotational flap insertion in maxillary and sphenoid sinus ostia in minimizing postoperative ostium stenosis.
Study design: A prospective study is done on 160 patients diagnosed as having chronic maxillary and/or sphenoid sinusitis patients who are divided into two equal groups, a study and a control group. All patients in the study group will undergo rotational flap coverage of the ostia and the control group arm will undergo middle meatal antrostomy and sphenoid ostium enlargement without flaps.
Results: Significant reduction in re-stenosis rate after 9 months of follow up.
Conclusion: Middle meatal antrostomy and sphenoidotomy by this technique have a higher patency rate than the standard techniques after 9 months of surgery.
... Based on physical exam and CT findings, some patients have also received reduction of a middle turbinate concha bullosa, and nasal valve repair as described by Dolan., et al. [18]. A resorbable chitosan sponge was placed in the middle meatus of all patients at the time of surgery, however none of the patients received nasal packing or septal splints [19]. All surgical complications and adverse events were recorded. ...
... Ponieważ opatrunki ulegające defragmentacji sprzy- jają gojeniu się ran [8], są one obecnie coraz powszechniej stosowane w zabiegach endoskopowej chirurgii zatok w celu poprawienia miejscowej hemostazy, zminimalizowania ry- zyka zrostów oraz przeciwdziałania lateralizacji środkowej małżowiny nosowej. Niewątpliwą zaletą opatrunków całko- wicie biodegradowalnych jest to, że nie trzeba ich usuwać [9], co zmniejsza ryzyko naruszenia struktur pooperacyjnych. ...
The aim:
This work was to compare an innovative solution, i.e. a fully biodegradable nasal packing Nasopore®, with a traditional one, in the aftercare of patients subjected to functional endoscopic sinus surgery.
Material and method:
Prospective, blinded study with sequential enrollment conducted at three study centres. One of the investigators evaluated during surgery the level of bleeding in each of the nasal cavities and at the end of surgery he applied the test packing, the biodegradable dressing Nasopore®, to one randomly chosen nasal cavity, and a control packing to the other one. The other investigator removed during aftercare the control packing and conducted the follow-up. During the control visits (24-48 hours, 10 and 30 days post-op.) the subjects evaluated their headache, pain in the nose, pressure in the forehead as well as their nasal obstruction.
Results:
A total of 39 women and 44 men at the age of 47 years on average (min. 19, max. 82) were qualified for the study. The largest differences between different types of nasal dressings were observed with regard to reduction of nasal obstruction in the fist 10 days after surgery (P<0.005). In relation to the pain in the area of the head and nose as well the pressure in the forehead on every visit, better outcomes were observed for the test dressing. Statistical difference (P<0.05) was observed on the fist follow-up visit for the headache and pressure in the forehead as well as on the fist and second visit for the pain in the nose.
Conclusion:
The fully biodegradable nasal dressing Nasopore® may constitute significant improvement and facilitation of aftercare in functional endoscopic sinus surgery while increasing the patients' satisfaction and lowering the postoperative discomfort.
... Its use was first described in 1951, examining the efficacy of rubber pneumatic packs. 1 In the years since, a variety of packing materials have been used, including polyethylene glycol-containing polyurethane foams (Nasopore®), petroleum ointment-soaked ribbon gauze, fingerstall packs, polyvinyl acetate sponge (Merocel®), and balloon tamponade devices. 2,3,4,5,6,7 However, these materials can serve as a nidus for inflammation and infection, cause pain and discomfort for patients post-operatively, and lead to mucosal trauma when removed from the nasal cavity. Over the years, numerous studies have been dedicated to determining whether there is a true clinical benefit to using intranasal packing, and if so, whether the clinical benefit is worth the cost, patient discomfort and risks imparted by their use. ...
Objectives/HypothesisIntranasal resorbable packing, such as Nasopore, is commonly used during sinus surgery despite a paucity of evidence that demonstrates clinical benefit. We theorized that Nasopore supports bacterial growth and biofilm formation. The DNABII family of bacterial nucleic acid binding proteins stabilizes the extracellular polymeric substance of the biofilm, thus protecting bacteria from host defenses and traditional antibiotics. We tested the hypothesis that use of anti-IHF antibodies in conjunction with antibiotics would enhance biofilm eradication from Nasopore. Study DesignIn vitro experiments. Methods
Nontypeable Haemophilus influenzae (NTHI) biofilms were grown on Nasopore. Following 24-hour incubation, biofilms were incubated for an additional 16 hours with either medium alone, naive rabbit serum, rabbit anti-IHF serum, amoxicillin/clavulanate, or anti-IHF serum+amoxicillin/clavulanate. Computer statistics (COMSTAT) analysis was performed on images of biofilms obtained via confocal microscopy. ResultsNTHI readily formed a biofilm on Nasopore. Treatment with amoxicillin/clavulanate alone mediated an increase in biomass by 92% to 6.63 (2)/(3) compared to incubation in sterile medium alone (3.46 (2)/(3)). Treatment with anti-IHF alone reduced the biomass by 77% to 1.29 (2)/(3) compared to incubation with naive rabbit serum (5.53 (2)/(3)). Anti-IHF+amoxicillin/clavulanate reduced biomass by 88% to 0.66 (2)/(3) (P <0.02) compared to incubation with naive rabbit serum. Conclusion
Antibiotics alone were ineffective in eradicating NTHI biofilms that had formed on Nasopore in vitro. Anti-IHF antibodies plus amoxicillin/clavulanate therapy synergistically reduced biofilm biomass by 88%. These data support clinical studies for the use of anti-IHF combined with antibiotics to reduce biofilm formation on intranasal packing.
The benefits of nasal packing after endoscopic sinus surgery (ESS) are still debated in the literature. Our aims were to evaluate the efficacy, and the clinical effects of a totally degradable nasal dressing used after ESS. Thirty patients with chronic rhinosinusitis with nasal polyps were enrolled in a prospective, randomized, double-blind, controlled study. Every patient underwent ESS and a polyurethane nasal dressing was used in one nasal fossa and the contralateral fossa was left unpacked. The extent of mucosal edema, crust formation, bleeding tendency, presence of synechiae, amount of nasal discharge, and the patency of the ostiomeatal complex (OMC) was evaluated during nasal endoscopy on the first, fourth, and twelfth postoperative weeks. All clinical findings were statistically analyzed. Endoscopy showed a significant improvement in the patency of the OMC on the side with resorbable material at 4 weeks after surgery. Follow-up at week 12 showed that in addition to the OMC patency scores, synechia formation and nasal discharge were also significantly improved in the packed fossa. Polyurethane packing is an effective alternative for nasal packing following functional endoscopic sinus surgery.
Background
In Indian clinical practice, conventional nasal packing for hemostasis after routine rhinological surgery is usually performed with Vaseline (paraffin) gauze, and rarely with glove-finger packs or tamponade balloons. These materials are tedious to pack and cause discomfort to the patient on removal. Newer nasal packs which have recently emerged in the Indian scenario are found to be more user-friendly, equally effective for hemostasis and less traumatic to the operated nasal mucosa. Most rhinologists today, prefer to use polyvinyl acetate sponge packs (Merocel/Ivalon) for tamponade after nasal surgery. These packs are very effective but non-absorbable and need to be removed which does not augur well with many patients postoperatively. The recent entry of a biodegradable synthetic polyurethane foam (Nasopore) as an alternative nasal packing material, has evoked new interest, which initiated this study.
Study method
This prospective randomized double-blinded controlled study was aimed to compare the clinical efficacy and patient comfort level, while using Merocel and Nasopore as packing material after functional endoscopic sinus surgery (FESS). This study included thirty adults who were diagnosed with moderate to severe bilaterally comparable chronic rhinosinusitis, who underwent FESS under general anesthesia and received size-matched nasal packs randomly - Merocel on one side and Nasopore on the other. The assessment of clinical efficacy of both packs with regards to ease of packing, hemostasis, pressure effects, infections and adhesions was done with a Diagnostic Nasal Endoscopy at first postoperative day, first week and fourth week after surgery. All Merocel packs were removed on the first postoperative day. Patient comfort levels for both packs were recorded with a standard symptom questionnaire marked on a visual analogue scale of ten and the results were statistically compared between the two groups.
Results
Comparable outcomes were found while using Merocel or Nasopore with regards to ease of nasal packing and control of postoperative bleeding. There was a statistical difference in the hemostatic property between the two materials in the immediate postoperative period. Five out of 30 patients developed reactionary bleeds with Nasopore, which required repacking with same material within the first 24 hours, but no further bleeds were noted. Two out of these five patients on the first postoperative day had migration of Nasopore toward the choana and had to be repacked with additional Nasopore. Sequential postoperative nasal endoscopy revealed that Nasopore is more mucosal friendly with lesser incidence of adhesions, synechiae, infection and edema, with better biocompatibility and safety. The major success with Nasopore was found to be, the fact that no pack removal was necessary, which immensely improved patient satisfaction and willingness to use the material when compared to Merocel. This was proved by the patient's symptom questionnaire which showed significant benefits of Nasopore over Merocel with regards to compliance and comfort levels.
Conclusion
Nasopore is a novel biodegradable synthetic material which is clinically as efficacious and patient-friendly as Merocel and is suitable for postoperative nasal packing after functional endoscopic sinus surgery. The clinical benefits of Nasopore and its outcomes among patients as recorded in our study, stands proof to support Nasopore as a successful packing material in rhinological surgery.
How to cite this article
Raghunandhan S, Kameswaran M, Thomas JK. A Prospective Double-Blinded Randomized Controlled Study Comparing the Efficacy of a Novel Biodegradable Synthetic Polyurethane Foam (Nasopore) vs Standard Polyvinyl Acetate Sponge (Merocel) as Packing Material after Functional Endoscopic Sinus Surgery: The First Indian Experience. Clin Rhinol An Int J 2014;7(3):105-111.
Postoperative infection remains a significant comorbidity of endoscopic sinus surgery (ESS) delayed healing, synechia formation, etc. The objective of this study was to compare the incidence of postoperative infection after ESS in patients receiving conventional postoperative oral antibiotic prophylaxis versus a synthetic bioabsorbable antibiotic-soaked nasal sponge used in the middle meatus (MM) in lieu of oral antibiotics.
A prospective randomized multicenter trial included 321 chronic rhinosinusitis patients undergoing minimally invasive ESS who received either 1 week of oral antibiotics and a saline-soaked bioabsorbable MM sponge (control group) or no oral antibiotics and the placement of a bacitracin-soaked bioabsorbable sponge in the MM (study group). Evaluations performed at baseline, 3-weeks, and 3-months postoperatively included the 20-item Sino-Nasal Outcome Test and nasal endoscopic examination.
The 3-week postoperative infection rate was not significantly different between the study (n = 165) and control groups (n = 156): 5.4% versus 3.8%; p > 0.05. In addition, there was no significant difference between the two patient groups on evaluation of MM granulations, synechia, middle turbinate lateralization, or sponge retention.
Antibiotic-soaked synthetic bioabsorbable MM sponges show equivalent efficacy in controlling post ESS infections compared with conventional postoperative oral antibiotics. Topical antibiotic delivery to the MM via bioabsorbable sponges may reduce the need for postoperative systemic antibiotics and provide a cost-effective alternative that eliminates the issues of antibiotic side effects, drug-drug interactions, and medication compliance in the postoperative setting.
Hyaluronan (HA) is a ubiquitous component of the extracellular matrix. HA and its derivatives have been used in the sinuses to reduce scarring and possibly promote wound healing. However, in recent animal studies, HA esters exhibited inflammatory effects. Mitomycin C (MMC) is another potential antiscarring treatment. This study prospectively evaluated the effects of three different HA constructs on wound healing in the rabbit maxillary sinus: (i) a novel cross-linked HA hydrogel, (ii) the cross-linked HA gel containing covalently bound MMC, and (iii) a commercially available woven HA ester (Merogel).
Ostia were created with a 4-mm otologic drill in the maxillary sinuses of 15 New Zealand white rabbits with one side randomly chosen for treatment. After 14 or 21 days the size of the maxillary ostia were recorded and the tissue was examined under light microscopy.
Sinuses treated with the novel HA and HA-MMC hydrogels showed an increased ostial diameter compared with untreated controls. Woven HA ester-treated sinuses showed no improvement, with a trend toward a smaller ostium than controls. Histological examination showed that woven HA ester tended to cause increased fibrosis and granulomatous inflammation, and heterophilia was slightly increased in the HA hydrogel-treated sinuses. Blinded observation noted foamy macrophages surrounding the residual woven HA ester in each specimen while no similar reaction was noted near the residual HA or HA-MMC hydrogels.
This study suggests that the degree of ostial narrowing, inflammation, and fibrosis depends on the formulation of the HA used. Minimal, if any, additional benefit is seen with addition of MMC to the HA hydrogel in this pilot study.
Background
A previous study by our group showed increased adhesions and granulation tissue in ethmoid cavities packed with FloSeal (FS) compared with those packed with thrombin-soaked gelatin foam after endoscopic sinus surgery (ESS). That study included 20 patients whose cavities were graded 6–8 weeks postoperatively. The goal of this study was to report long-term follow-up on this cohort.
Methods
At least 1 year follow-up was available in 18/20 patients. The number of office procedures required to lyse adhesions during the follow-up period was tabulated also. Pathology was available from one patient who underwent lysis of adhesions on an FS side. The histopathological findings are presented.
Results
The mean follow-up period was 21.4 (±2.3) months, and none of the 18 patients required revision ESS during this interval. The overall incidence of adhesions (p = 0.013) and the number requiring lysis of adhesions (p = 0.046) were both greater in the FS group. During the interval between previous study evaluation (6–8 weeks postop) and last follow-up, five FS sides required a total of seven procedures to lyse adhesions. Silent adhesions were observed in an additional five FS sides. Although asymptomatic adhesions were observed in two thrombin-soaked gelatin sides at last examination, none underwent lysis. Biopsy of an adhesion from a patient packed with FS 25 months earlier revealed incorporated foreign material.
Conclusion
FS appears to be associated with scar tissue formation and may be incorporated into recovering mucosa. Use of FS may increase the degree of postoperative care required after ESS.
The aim of this study was to determine the incidence, outcomes, and risk factors for synechia formation after endoscopic sinus surgery (ESS) and middle turbinate medialization with and without FloSeal.
A retrospective review was performed of patients who underwent primary ESS with middle turbinate medialization, with or without the placement of FloSeal. Medialization was performed with the placement of an absorbable conchopexy suture and silastic splint. Operative variables and outcomes were analyzed to identify risk factors for synechia formation.
One hundred thirty-five patients underwent medialization alone and 37 patients underwent medialization with placement of FloSeal. Overall, synechia formation was noted in 16 patients (9.3%). A statistically significant higher incidence of synechia formation was noted in patients who underwent middle turbinate medialization with the placement of FloSeal versus medialization alone (18.9% versus 6.7%). The incidences of intraoperative complications (6.2% versus 4.7%) and postoperative complications (6.2% versus 7%) were similar between patients with and without synechia, respectively. Patients experiencing synechia, however, underwent a statistically significant higher rate of revision procedures (25% versus 5.1%).
Despite adequate prevention with middle turbinate medialization, synechia formation after ESS may result in higher rates of revision procedures. The placement of FloSeal in conjunction with middle turbinate medialization may result in a higher incidence of synechia formation.
A prospective study was performed to compare Telfa(®), paraffin gauze, Merocel(®) and BIPP used post-operatively following septal or turbinate surgery. Packs were assessed in terms of patient comfort, control of bleeding and ease of removal. There was little to choose between the packs while they were in situ and there was no significant difference in ease of removal. On removal the Telfa(®) and paraffin gauze were associated with less discomfort and less bleeding than BIPP or Merocel(®) (p<0.05).
The study sought to evaluate the effects of MeroGel (Medtronic Xomed Surgical Products, Jacksonville, FL) hyaluronic acid sinonasal implants by using a mouse model. We expected that this material would dissolve, elicit minimal inflammation, and leave intact mucosa. However, pilot data showed that MeroGel may be osteogenic. The present work focuses on the description and quantification of these bony changes.
Animal experiment.
The effects of MeroGel were evaluated using sinonasal and calvarial implants in C57BL/6 mice. The calvarial experiments employed both light microscopy (bone histomorphometry) and fluorochrome labeling (mineral apposition). Each implant study was subdivided into normal control animals, sham-operated control animals, a foreign body control, and MeroGel implants. MeroGel was also placed within subcutaneous pockets remote from bone. All mice were killed 1 month after surgery. Both percentage of bone area within the sinonasal cavity and total calvarial bone area were quantified and compared. Fluorochrome images and the subcutaneous implants were examined qualitatively.
MeroGel placement engendered new bone formation within the nasal lumen of mice. Compared with normal control animals, sham-operated control animals, and a foreign body control, this increase was statistically significant. The calvaria from MeroGel-implanted mice were thickened as compared with normal animals, sham-operated control animals, and a foreign body control. Tetracycline labeling demonstrated mineral apposition along the dorsal and ventral surfaces of the calvaria and within enlarged marrow spaces. MeroGel placed subcutaneously did not engender bone formation.
MeroGel, a unique esterified form of hyaluronic acid, induced bone formation within the sinonasal cavity and on the calvaria of mice implanted with it. Our experiments suggest that, when placed adjacent to traumatized, remodeling bone, MeroGel may have osteogenic potential.
There is a paucity of knowledge about the healing of the nasal respiratory mucosa after endoscopic sinus surgery (ESS). Nasal packs often are placed after ESS in an attempt to reduce adhesions but the effect of these packs on the healing of the nasal mucosa is not known.
A standardized normal animal model (the sheep) was used to examine the healing of the nasal epithelium after ESS. A full-thickness wound was created in the nasal mucosa and either packed with a dissolvable hyaluronic acid-based pack or left unpacked to serve as control. The wounded areas were biopsied at 28, 56, 84, and 112 days postinjury and epithelialization, and cilial regeneration was assessed by light microscopy and scanning electron microscopy.
The wounds with the dissolvable hyaluronic acid-based packs showed no differences in reepithelialization up to 84 days postwounding. However, a significant increase in reepithelialization was observed on day 84 in packed wounds compared with unpacked controls, indicating an increased rate of healing at that time point. In addition, there was a significant increase in the epithelial height in the packed wounds on day 28, indicating that packing was affecting the epithelial maturity of the mucosa. No significant difference was observed in cilial regeneration between the packed and control wounds.
Application of the hyaluronic acid-based nasal packs to wounds after ESS may improve reepithelialization of the nasal mucosa but appears to have minimal effect on reciliation at the time points studied in normal-healing wounds.
The optimal form of nasal packing after endoscopic sinus surgery (ESS) still has not been established Although wide variations exist among sinus surgeons, the goals are adequate hemostasis, rapid healing, and patient comfort. Preliminary studies indicated that FloSeal (FS), a novel absorbable hemostatic paste used as a nasal pack, was associated with minimal postoperative discomfort and effective hemostasis. This study was designed to evaluate the effects of this agent on mucosal healing in ESS.
Twenty consecutive patients underwent bilateral ESS. For each patient, one ethmoid cavity was randomized to receive FS and the other received thrombin-soaked gelatin foam. The extent of granulation tissue and adhesion formation was evaluated at 6-8 weeks after surgery.
No significant differences were observed between the FS and the thrombin-soaked gelatin foam groups with respect to the preoperative Lund-Mackay score, extent of surgery performed, or need for additional nasal packing. However, the FS group showed clear trends toward increased granulation tissue (p = 0.007) and adhesion (p = 0.006) formation.
Absorbable hemostatic agents are associated with a high degree of patient comfort and provide hemostasis comparable with traditional techniques. Different materials may induce differential patterns of mucosal healing, potentially affecting the ultimate result of ESS.
In this study, we compared postoperative synechia rates and morbidity for different middle meatal (MM) stents after minimally invasive sinus techniques (MIST).
In a prospective study, we included 100 patients with bilateral chronic sinusitis undergoing MIST at a tertiary care facility with a single surgeon.
For all patients, MeroGel stents were placed in the right MM, Gelfilm stents were placed in the left MM. Follow-up consisted of 3 postoperative visits between weeks 1 and 12 with endoscopic evaluation for synechia, granulation tissue, stent retention, nasal obstruction, headache, and infection.
Synechia developed in 4 patients on the left and in none on the right (P = 0.04). There were no significant side-specific differences regarding postoperative nasal congestion, headache, or sinusitis. Mean stent retention time was 7.9 days for MeroGel and 5.6 days for Gelfilm (P = 0.0004).
Compared with Gelfilm, Merogel MM stents produced less synechia; Merogel retains its position in the MM longer than Gelfilm; and the incidence of postoperative MM synechia can be reduced when absorbable MM stents are used in conjunction with MIST.
Recently, nasal packing made of absorbable biomaterial has become increasingly popular. Although absorbable packs are effective for hemostasis, their impact on healing mucosa is unknown. Some have felt that a biocompatible sinus dressing actually may enhance healing, particularly in areas where the mucosa has been stripped. The aim of this study was to determine the effect of topical MeroGel and FloSeal on paranasal sinus mucosal healing in a rabbit model.
Bilateral maxillary sinuses of 12 New Zealand white rabbits were surgically opened and stripped of mucosa. The left maxillary sinus of six rabbits had sterile saline-soaked MeroGel placed in the antrum, and the other six rabbits received FloSeal. The right maxillary sinuses of all 12 animals were stripped and otherwise untreated to serve as stripped controls. The animals were killed at 2 weeks and specimens were examined by light microscopy.
MeroGel-treated mucosa showed extensive fibrosis of the basal lamina and lamina propria, complete loss of surface epithelium, and loss of the mucociliary blanket. There was minimal resorption of the MeroGel, and MeroGel fibers were frankly incorporated into the regenerated epithelium, associated with an exuberant lymphocytic infiltrate. FloSeal-treated mucosa showed similar fibrosis of the basal lamina and lamina propria with loss of the mucociliary blanket, although to a lesser degree than the MeroGel- treated group. FloSeal showed similar incorporation into the healed mucosa with lymphocytosis. Controls showed expected submucosal gland reduction, lamina propria fibrosis, and loss of cilia, but the lamina propria fibrosis seen in the MeroGel and FloSeal groups was markedly more prominent.
In a rabbit model, MeroGel and FloSeal appear to increase reactionary fibrosis of healing mucosa. These agents also appear to be incompletely resorbed and grossly incorporated into healing tissue. Mucosal healing may be impaired by the application of these agents.
The safety and efficacy of a new hemostatic sealant, based on a gel with collagen derived particles and topical thrombin (FloSeal, Fusion Medical Technologies, Inc. Fremont, CA) were assessed as an alternative to nasal packing for hemostasis in functional endoscopic sinus surgery. In a prospective clinical study of 50 patients undergoing bilateral endoscopic anterior ethmoidectomy, 2 ml FloSeal was used after surgery to stop bleeding. The results were compared to a control group of 50 patients with Merocel packing and showed that intraoperative hemostasis was rapid and equal in both groups. The main advantages of the new hemostatic sealant included a higher degree of comfort during postoperative nasal breathing and absence of complaints due to pressure or pain. There was only one case of postoperative bleeding on the 6th day, which required nasal packing. There were no more cases of stenoses or synechia in the ostiomeatal complex than were found in the Merocel group. No systemic side effects due to FloSeal were observed. This specific hemostatic sealant was shown to be a safe and efficacious alternative method for hemostasis in endoscopic sinus surgery with high patient satisfaction and an easy and fast mode of application.
The aim of this study was to determine whether there was any benefit or detrimental consequences of placing a hyaluronic acid pack (Merogel) into the middle meatus after endoscopic sinus surgery (ESS).
A randomized controlled blinded study was performed in 42 patients with chronic sinusitis undergoing ESS. The patients were randomized to receive Merogel on one side and no packing on the other side. Patients were assessed at 2, 4, and 6-8 weeks after surgery and the presence of synechia, edema, and infection was noted with the observer blinded to the side that had received the Merogel.
At 2 weeks the side packed with Merogel had 35% synechiae, 83% edema, and 30% mucopurulent discharge and on the control side the figures were similar with 22.5% synechiae, 83% edema, and 28% mucopurulent discharge. In both groups these figures improved over the observation period but percentages in the groups remained similar. At no time point was the difference between the packed and unpacked sides statistically significant for any of the measures when assessed with Fisher's exact test.
Merogel nasal packing has no significant beneficial or detrimental effect in terms of synechia, edema, or infection when placed in the middle meatus after ESS.
Objective:
This guideline provides evidence-based recommendations on managing sinusitis, defined as symptomatic inflammation of the paranasal sinuses. Sinusitis affects 1 in 7 adults in the United States, resulting in about 31 million individuals diagnosed each year. Since sinusitis almost always involves the nasal cavity, the term rhinosinusitis is preferred. The guideline target patient is aged 18 years or older with uncomplicated rhinosinusitis, evaluated in any setting in which an adult with rhinosinusitis would be identified, monitored, or managed. This guideline is intended for all clinicians who are likely to diagnose and manage adults with sinusitis.
Purpose:
The primary purpose of this guideline is to improve diagnostic accuracy for adult rhinosinusitis, reduce inappropriate antibiotic use, reduce inappropriate use of radiographic imaging, and promote appropriate use of ancillary tests that include nasal endoscopy, computed tomography, and testing for allergy and immune function. In creating this guideline the American Academy of Otolaryngology-Head and Neck Surgery Foundation selected a panel representing the fields of allergy, emergency medicine, family medicine, health insurance, immunology, infectious disease, internal medicine, medical informatics, nursing, otolaryngology-head and neck surgery, pulmonology, and radiology.
Results:
The panel made strong recommendations that 1) clinicians should distinguish presumed acute bacterial rhinosinusitis (ABRS) from acute rhinosinusitis caused by viral upper respiratory infections and noninfectious conditions, and a clinician should diagnose ABRS when (a) symptoms or signs of acute rhinosinusitis are present 10 days or more beyond the onset of upper respiratory symptoms, or (b) symptoms or signs of acute rhinosinusitis worsen within 10 days after an initial improvement (double worsening), and 2) the management of ABRS should include an assessment of pain, with analgesic treatment based on the severity of pain. The panel made a recommendation against radiographic imaging for patients who meet diagnostic criteria for acute rhinosinusitis, unless a complication or alternative diagnosis is suspected. The panel made recommendations that 1) if a decision is made to treat ABRS with an antibiotic agent, the clinician should prescribe amoxicillin as first-line therapy for most adults, 2) if the patient worsens or fails to improve with the initial management option by 7 days, the clinician should reassess the patient to confirm ABRS, exclude other causes of illness, and detect complications, 3) clinicians should distinguish chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis from isolated episodes of ABRS and other causes of sinonasal symptoms, 4) clinicians should assess the patient with CRS or recurrent acute rhinosinusitis for factors that modify management, such as allergic rhinitis, cystic fibrosis, immunocompromised state, ciliary dyskinesia, and anatomic variation, 5) the clinician should corroborate a diagnosis and/or investigate for underlying causes of CRS and recurrent acute rhinosinusitis, 6) the clinician should obtain computed tomography of the paranasal sinuses in diagnosing or evaluating a patient with CRS or recurrent acute rhinosinusitis, and 7) clinicians should educate/counsel patients with CRS or recurrent acute rhinosinusitis regarding control measures. The panel offered as options that 1) clinicians may prescribe symptomatic relief in managing viral rhinosinusitis, 2) clinicians may prescribe symptomatic relief in managing ABRS, 3) observation without use of antibiotics is an option for selected adults with uncomplicated ABRS who have mild illness (mild pain and temperature <38.3 degrees C or 101 degrees F) and assurance of follow-up, 4) the clinician may obtain nasal endoscopy in diagnosing or evaluating a patient with CRS or recurrent acute rhinosinusitis, and 5) the clinician may obtain testing for allergy and immune function in evaluating a patient with CRS or recurrent acute rhinosinusitis.
Disclaimer:
This clinical practice guideline is not intended as a sole source of guidance for managing adults with rhinosinusitis. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and may not provide the only appropriate approach to diagnosing and managing this problem.
The purpose of this study was to investigate the quality of mucosal regeneration in the presence of two different resorbable dressings derived from hyaluronic acid (HA): HA-carboxymethyl cellulose (HACMC) and esterified HA (HYAFF). A prospective randomized animal study was performed.
Twelve New Zealand white rabbits underwent bilateral maxillary sinusomy via a canine fossa approach. Each sinus was stripped circumferentially, except for the mucosa along the medial wall in the region of the natural ostium. Each of the 24 sinuses was then packed with either HACMC (n = 8) or HYAFF (n = 8) or left as an unpacked control (n = 8). After 14 days, each animal was killed and the sinus contents were evaluated histologically by a blinded pathologist.
Criteria for optimal mucosal regeneration included a continuous layer of ciliated columnar epithelium with normal-appearing submucous glands and lack of both inflammatory infiltrate and fibrosis. Optimal regeneration was observed in 5/8 (62.5%) of the HACMC specimens, 1/8 (12.5%) of the HYAFF specimens, and 6/8 (75%) of the controls. The trend toward optimal regeneration using either HACMC or control was statistically significant when compared with HYAFF (p = 0.03). HYAFF specimens also were more likely to exhibit atrophic subepithelial glands in the regenerated mucosa. Polarizable foreign material was observed in 1/8 (12.5%) of the HACMC specimens and 2/8 (25%) of the HYAFF specimens.
The quality of epithelial regeneration is potentially affected by the form of HA present in the healing milieu. In this series, the most optimal healing characteristics were seen in unpacked controls. Between the preparations of HA studied, HACMC exhibited more favorable healing patterns, which were nearly similar to controls.
Endoscopic sinus surgery techniques and technologies have undergone rapid development over the past two decades. Recently, image guided systems have been implemented in endoscopic sinus surgery, carrying the promise of increased safety during surgery. This review compiles available data regarding the incidence of complications in endoscopic sinus surgery, the trends over time, and the impact of image guided surgery on complication rates.
Reporting of complications in endoscopic sinus surgery is widely variable, confounding attempts to establish accurate data regarding complication rates. Few prospective, randomized trials exist comparing the safety of functional endoscopic sinus surgery with other surgical techniques. Major complications occur in 0-1.5% of cases and minor complications occur in 1.1-20.8% of functional endoscopic sinus surgery cases. Powered instrumentation does not appear to affect the incidence of complications, but may increase the severity of complications. It is unclear whether image guided surgery results in lower complication rates. Practical and ethical considerations make randomized trials to evaluate this issue problematic.
In order to maximize safety, functional endoscopic sinus surgery surgeons must individually and collectively audit current practice, report complications in a systematic way, utilize available technology appropriately to support safe surgery, and diligently refine surgical technique as well as the systems supporting endoscopic surgical practice.
Nasal packing usually is placed after endoscopic sinus surgery (ESS) to control hemorrhage, but also may be used to prevent adhesions from forming and promote faster healing of damaged mucosa.
A literature review was performed to identify all forms of scientifically evaluated absorbable packing for ESS. Only English studies identifiable within the PubMed database were included. Studies were categorized by level of evidence and evaluated for methodological errors.
Thirty-eight studies met the inclusion criteria. There was a diverse range of article evidence and quality.
The most effective hemostatic agent currently available is FloSeal; however, this product causes an increase in adhesion formation. For the purpose of preventing adhesions, resorbable packs appear to have no benefit over either nonresorbables or no packing. If the middle turbinate is unstable at the conclusion of surgery, suturing it to the septum may reduce adhesions. Although mitomycin C, hyaluronic acid, and retinoic acid all have shown potential in these roles, to date, none have shown to be useful in the post-ESS chronic sinusitis human patient.
- Wormold PJ